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喉显微手术中膈肌超声评估新斯的明与 sugammadex 恢复神经肌肉阻滞后肌功能的比较:一项随机对照试验。

Comparison of neostigmine vs. sugammadex for recovery of muscle function after neuromuscular block by means of diaphragm ultrasonography in microlaryngeal surgery: A randomised controlled trial.

机构信息

From the Department of Health Sciences, Azienda Ospedaliero Universitaria Careggi (IC, DO, BL, ARDG, CA) and Department of Neurosciences, Psychology, Drug Research and Child Health, University of Florence, Florence, Italy (LT).

出版信息

Eur J Anaesthesiol. 2020 Jan;37(1):44-51. doi: 10.1097/EJA.0000000000001055.

DOI:10.1097/EJA.0000000000001055
PMID:31356374
Abstract

BACKGROUND

Postoperative residual curarisation (PORC) is a risk directly related to the use of neuromuscular blocking agents during surgical procedures. Acceleromyography is distressing for conscious patients when assessing PORC. Diaphragm ultrasonography could be a valid alternative.

OBJECTIVES

The primary objective was to achieve a 28% lower incidence of PORC in patients who, after rocuronium administration, received neostigmine or sugammadex at 30 min after surgery. To assess PORC, diaphragm ultrasonography was used, and thickening fractioning [the difference of thickness at the end of inspiration (TEI) and at the end of expiration (TEE), normalised for TEE (TEI - TEE/TEE)] was measured. PORC was defined as thickening fractioning of 0.36 or less. The secondary object was the comparison, in the two treatment groups, of the return to baseline thickening fractioning at 30 min after surgery (ΔTF30).

DESIGN

Randomised, double-blind, single-centre study.

SETTING

University Hospital Careggi, Florence, Italy.

PATIENTS

Patients of American Society Anesthesiologists' physical status 1 or 2, 18 to 80 years, receiving rocuronium during microlaryngeal surgery.

INTERVENTIONS

At the end of surgery participants were randomised to receive neostigmine (NEO group) or sugammadex (SUG group) as the reversal drug. Thickening fractioning and ΔTF30 were evaluated at baseline and at 0, 10 and 30 min after surgery.

MAIN OUTCOME MEASURES

TEE and TEI at each time point.

RESULTS

A total of 59 patients with similar demographic characteristics were enrolled. An association between lack of recovery (thickening fractioning ≤0.36) and drug treatment was only observed at 0 min (SUG vs. NEO, P < 0.05). Concerning ΔTF, at 30 min more patients in the SUG group returned to baseline than those in the NEO group (P < 0.001), after adjusting for side (P = 0.52), baseline thickening fractioning (P < 0.0001) and time of measurement (P < 0.01).

CONCLUSION

We found an early (0 min) but not long-lasting (30 min) association between diaphragm failure and treatment allocation; a full recovery in baseline diaphragm function was observed only in patients receiving sugammadex. We cannot exclude that further differences have not been found due to interpatients variability in assessing diaphragm contractility by ultrasonography.

TRIAL REGISTRATION

EudraCT Identifier: 2013-004787-62, Clinicaltrials.gov Identifier: NCT02698969.

摘要

背景

术后残余肌松(PORC)是与手术过程中使用神经肌肉阻滞剂直接相关的风险。在评估 PORC 时,加速度描记术会使意识清醒的患者感到不适。膈肌超声检查可能是一种有效的替代方法。

目的

主要目的是在手术后 30 分钟给予新斯的明或琥珀酸舒更葡糖钠的患者中,将 PORC 的发生率降低 28%。使用膈肌超声检查评估 PORC,并测量厚度分数(吸气末(TEI)和呼气末(TEE)之间的厚度差异,TEE 归一化(TEI-TEE/TEE))。PORC 的定义为厚度分数为 0.36 或更低。次要目的是比较两组患者在手术后 30 分钟(ΔTF30)时恢复到基线厚度分数的情况。

设计

随机、双盲、单中心研究。

地点

意大利佛罗伦萨卡雷吉大学医院。

患者

接受罗库溴铵进行微喉镜手术的美国麻醉师协会身体状况 1 或 2 级、18 至 80 岁的患者。

干预措施

手术结束时,参与者被随机分配接受新斯的明(NEO 组)或琥珀酸舒更葡糖钠(SUG 组)作为逆转药物。在基线和手术后 0、10 和 30 分钟评估厚度分数和ΔTF30。

主要观察指标

每个时间点的 TEE 和 TEI。

结果

共纳入了 59 名具有相似人口统计学特征的患者。仅在 0 分钟时观察到恢复不良(厚度分数≤0.36)与药物治疗之间存在关联(SUG 与 NEO,P<0.05)。关于ΔTF,在 30 分钟时,与 NEO 组相比,SUG 组更多的患者恢复到基线(P<0.001),调整侧(P=0.52)、基线厚度分数(P<0.0001)和测量时间(P<0.01)后。

结论

我们发现膈肌功能障碍与治疗分配之间存在早期(0 分钟)但不持久(30 分钟)的关联;只有接受琥珀酸舒更葡糖钠的患者才能观察到基线膈肌功能的完全恢复。我们不能排除由于超声评估膈肌收缩力的个体间变异性,尚未发现进一步的差异。

试验注册

EudraCT 标识符:2013-004787-62,Clinicaltrials.gov 标识符:NCT02698969。

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